The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.

The Tornier Total Elbow Prosthesis is intended for cemented use only.

Device Description

Total Elbow replacement are used to treat a number of clinical conditions such are severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Total Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.

The present Device Modification submission corresponds to :

the addition of one ulnar longer stem with the same diameter to the previous range with the same indications for use already covered by the previous 510(k) clearance,
the addition of the possibility to manufacture some components in an other grade of CoCr alloy, the manufacturing method is unchanged compared to the previous 510(k) clearance,
the modification of the locking mechanism of the ulnar cap. -

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Tornier Total Elbow Prosthesis." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've described for a typical AI/software device.

Instead, this document is focused on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for many medical devices in the US to gain market clearance. This type of submission relies on showing that the new device is as safe and effective as existing, cleared devices, rather than conducting a separate study to establish novel performance criteria directly.

Therefore, many of your requested items are not applicable to this type of regulatory submission. I will explain why each item is not present in this document:

1. A table of acceptance criteria and the reported device performance:

Not applicable. This document establishes substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is comparable to already cleared devices. It does not define new, specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) with corresponding reported performance from a dedicated study. The "performance" assessment here is generally implicit, based on material properties, design changes, and intended use being similar to predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. There is no "test set" in the context of an algorithm evaluation as this is a physical implant. The submission refers to and compares the new device with existing predicate devices based on their established safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This pertains to a physical implant, not an AI or diagnostic device that requires expert-established ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is relevant for diagnostic performance studies, not for a physical implant's regulatory submission of this nature.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. An MRMC study is relevant for AI-assisted diagnostic tools impacting human reader performance. This document is for a physical elbow implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. There is no "ground truth" as would be defined for a diagnostic or AI device. The "truth" in this context is the safety and effectiveness profile of the predicate devices.

8. The sample size for the training set:

Not applicable. No AI/algorithm is being trained for this physical implant.

9. How the ground truth for the training set was established:

Not applicable. No AI/algorithm is being trained, so no training set or its ground truth is mentioned.

Summary of the document's content, focusing on what is present and relevant to "proving" safety and effectiveness in this context:

The document describes a Special 510(k) submission for a Tornier Total Elbow Prosthesis. The "proof" of safety and effectiveness lies in demonstrating substantial equivalence to previously cleared devices.

Acceptance Criteria (Implicit via Substantial Equivalence):
The primary "acceptance criterion" for this 510(k) is that the modified Tornier Total Elbow Prosthesis is substantially equivalent in terms of indications for use, technological characteristics, and safety/effectiveness to predicate devices already cleared by the FDA. This means:

It serves the same clinical purpose.
It has similar technological characteristics (materials, design principles, etc.).
Any differences do not raise new questions of safety or effectiveness.

Reported Device Performance (Implicit via Substantial Equivalence):
The document asserts that the Tormier Total Elbow Prosthesis "is intended to accomplish these goals" (restore elbow function, reduce pain) and that the modifications (new ulnar stem, alternative CoCr alloy, locking mechanism change) are within the scope of existing indications and do not alter fundamental performance.

Study/Evidence that Proves Acceptance Criteria:

Predicate Device Comparison: The core of the "study" is a comparison to legally marketed predicate devices:
- Coonrad / Morrey Total Elbow, Zimmer (K973357)
- Sorbie - Questor Elbow System, Wright (K955099)
- Tornier Total Elbow Prosthesis, Tornier (K000003 and K011567) (previous versions by the same manufacturer)
Device Description and Modifications: The submission details the modified aspects:
- Addition of one ulnar longer stem (same diameter, same indications).
- Addition of possibility to manufacture some components in another grade of CoCr alloy (ISO 5832-12 or ISO 5832-4 for humeral components; ISO 5832-7 or ISO 5832-12 or ISO 5832-4 for ulnar/radial components), while maintaining an unchanged manufacturing method.
- Modification of the locking mechanism of the ulnar cap.
Materials: The materials used are specified and conform to international standards (ISO 5832 for CoCr alloys and UHMWPE). This implies that material performance (biocompatibility, mechanical properties) is well-established and accepted.
Indications for Use: The indications for use are explicitly stated and aligned with those of predicate devices:
- Relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic elbow disease.
- Correction of functional deformities.
- Revision procedures.
- Treatment of unmanageable fractures.
- Intended for cemented use only.

By showing that the new device is either identical or very similar in design, materials, and intended use to these already cleared devices, and that the modifications do not introduce new safety or effectiveness concerns, the FDA determines that the device is "substantially equivalent" and grants clearance. This is the "proof" within the context of a 510(k) submission for this type of device.

Summary

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031218

Implants Chirurgicaux

MAY 1 6 2003

Summary of Safety and Effectiveness information Special 510(k) - Tornier Total Elbow Prosthesis

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name
Trade name:	Tornier Total Elbow Prosthesis
Common name:	Total Elbow Prosthesis
Classification name:	Elbow joint metal/polymer semi-constrained cemented prosthesisElbow joint metal/metal or metal/polymer constrained cemented prosthesis

Submitter Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
Company contact Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille.lemery@tornier.fr
Classification Device class: Class II Classification panel: Orthopedic Product code: JDB and JDC § 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis & 888.3150 Elbow joint metal/metal or metal/polymer constrained cemented prosthesis

5) Equivalent / Predicate device

Coonrad / Morrey Total Elbow, Zimmer (K973357) Sorbie - Questor Elbow System, Wright (K955099) Tornier Total Elbow Prosthesis, Tornier (K000003 and K011567)

Image /page/0/Picture/11 description: The image shows a logo with two letters, "T" and "P", intertwined within a hexagon. The letter "T" is at the top, partially overlapping the letter "P" below it. The logo is black and white, with the letters and the outline of the hexagon in black against a white background.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

Page 1/ page 2

SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Implants Chirurgicar

6) Device description

The present Device Modification submission corresponds to :

the addition of one ulnar longer stem with the same diameter to the previous range with the same indications for use already covered by the previous 510(k) clearance,
the addition of the possibility to manufacture some components in an other grade of CoCr alloy, the manufacturing method is unchanged compared to the previous 510(k) clearance,
the modification of the locking mechanism of the ulnar cap. -

7) Materials

Humeral implant components are available in CoCr alloy according to standard ISO 5832-12 or ISO 5832-4. The ulnar and radial components are made of CoCr alloy according to standard ISO 5832-7 or ISO 5832-12 or ISO 5832-4, and UHMWPE according to standard ISO 5834-2.

8) Indications

The Tornier Total Elbow Prosthesis is intended for cemented use only.

KO 3/2/18

Page 2/ page 2

Image /page/1/Picture/14 description: The image is a black and white logo. The logo consists of a hexagon shape with a stylized letter "T" inside. The letter "T" is bold and has a unique design, with the top part of the "T" extending beyond the hexagon's top edge.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mireille Lémery Regulatory Affairs & Quality Engineer Tornier S.A. ZIRST – 161, rue Lavoisier 38330 Montbonnot - France

MAY 1 6 2003

Re: K031218

Trade/Device Name: Tornier Total Elbow Prosthesis Regulation Numbers: 21 CFR 888.3150; 21 CFR 888.3160 Regulation Names: Elbow joint metal/polymer constrained cemented prosthesis. Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JDC, JDB Dated: April 2, 2003 Received: April 17, 2003

Dear Ms. Lémery:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Mireille Lémery

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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00S	C
		ALL CHRIS COLLEGIA

510(k) Number (if known): K031218

Tornier Total Elbow Prosthesis Device name:

Indication for use:

The Tornier Total Elbow Prosthesis is intended for cemented use only.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number	K031218
Prescription use	OR Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Regulation Number and Section

§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.